AnesthesiaARTEMIDENCT04839445
ESP vs TAP in Total Laparoscopic Hysterectomy
A study testing General anesthesia + TAP block and General anesthesia + ESP block in people with Anesthesia and Gynecologic Cancer, run by AUSL Romagna Rimini at 1 site in Italy.
Trial summary
The anesthetic techniques for videolaparoscopic surgery include general anesthesia, and locoregional anesthesia in association with general anesthesia in order to reduce or abolish post-operative pain with a simultaneous reduction in the use of opioids and days of hospital stay. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Anesthesia, Gynecologic Cancer
- What is being tested?
- General anesthesia + TAP block and General anesthesia + ESP block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteItaly
- Study dates
- 22 Feb 2021to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American society of anesthesiologists (ASA) I-III risk
- no contraindication to the execution of the peripheral nerve block
- signature of the informed consent
- total videolaparoscopic surgery (no conversion to open-abdomen)
Who cannot join
- allergies and / or contraindications to the administration of the drugs used in the study
- infections and injuries at the puncture site
- BMI ≥40
- history of opioid abuse or use of opioids in chronic therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Efficacy of Ultrasound-guided Erector Spinae Place Block Versus Transversus Abdominis Plane Block for Intra and Postoperative Pain Control in Total Laparoscopic Hysterectomy: a Randomized Controlled Trial
The anesthetic techniques for videolaparoscopic surgery include general anesthesia, and locoregional anesthesia in association with general anesthesia in order to reduce or abolish post-operative pain with a simultaneous reduction in the use of opioids and days of hospital stay.
From the studies published so far on videolaparoscopic surgery in general, it is clear that the transversus abdominal plane (TAP) block could have a role in reducing the stretch wall pain secondary to pneumoperitoneum and incisional, although its role in this regard is not yet clear, nor significant statistically results have been produced. The use of erector spinae plane (ESP) block for the management of visceral pain is finding more and more space in the literature, with promising results.
Read more
For videolaparoscopic gynecological surgery, the techniques of locoregional anesthesia studied in association with general anesthesia, up to now, include wall blocks, TAP block and ESP block, while neuraxial anesthesia has no indications in this regard.
Although videolaparoscopic hysterectomy is considered less painful than the open-abdomen technique, it requires careful management of post-operative pain. The pain of this surgery is the result of the sum of incisional pain, at the insertion points of the laparoscopic trocars, pain due to pneumoperitoneum usually referred to the shoulder, and visceral pain purely dependent on surgical maneuvers. There is currently no strong evidence to support the use of locoregional anesthesia techniques in videolaparoscopic gynecological surgery. Few studies have been produced about this topic, and they are mostly case series or randomized controlled trials that take into consideration only one technique among those possible. To date, no study compares the various techniques to evaluate the possible superiority of one over the other.
In our hospital anesthesists carry out, in normal clinical practice, all the aforementioned local anesthesia techniques.
The purpose of our work is to evaluate, with a randomized non-sponsored study, the efficacy of the ESP block and the TAP block for intra and post-operative pain control in videolaparoscopic hysterectomy, and to compare the two techniques.
Based on the evidence available in the literature, the two techniques are already part of the current clinical practice of the Anesthesia Unit of our hospital and the choice of one technique over the other is based on anesthetist clinical evaluation to date. The anesthetists involved in the study are adequately trained on both anesthetic procedures.
- Conditions
- Anesthesia, Gynecologic Cancer
- Being tested
- General anesthesia + TAP block, General anesthesia + ESP block
- Keywords
- Transversus Abdominal Plane Block, Erector Spinae Plane Block, General Anesthesia, Laparoscopic Hysterectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General anesthesia + TAP blockProcedure or surgery
Post induction TAP block for intra and postoperative analgesia.
General anesthesia + ESP blockProcedure or surgery
Pre induction ESP block for intra and postoperative analgesia.
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia + TAP block | Active comparator | Induction: remifentanil in total intravenous anesthesia (TIVA), Propofol 2 mg/kg/h and Rocuronium 0.6 mg/kg. Transversus abdominis plane (TAP) block: 20 minutes before surgery. Ropivacaine 0.37% 20ml + dexamethasone 2mg per side. Maintenance: TIVA with Propofol, the infusion rate will be adjusted according to the bispectral index system (BIS) values (30 <BIS <50). Patients will receive additional remifentanil by infusion at 0.02 mcg/kg/min per time if blood pressure and heart rate values exceed 20% pre-operative baseline values. Additional rocuronium 0.1 mg/kg based on clinical needs and train of four (TOF) monitoring. Analgesic starter bolus: 30 minutes before the end of the surgery, paracetamol 1 gr ev and ketorolac 30 mg ev. Postoperative pain: paracetamol 1 gr ev every 8 hours for 36 hours; ketorolac 30 mg ev if NRS >4 / morphine 2 mg ev if NRS >4 30 min after ketorolac administration. In case of nausea and vomiting ondansetron 4 mg ev. Receives: Procedure: General anesthesia + TAP block |
| General anesthesia + ESP block | Active comparator | Erector spinae plane (ESP) block: 20 minutes before surgery. T8 level bilaterally, ropivacaine 0.37% 20ml + dexamethasone 2mg per side.
Induction: Remifentanil in TIVA, Propofol 2 mg/kg/h and Rocuronium 0.6 mg/kg. Maintenance: TIVA with Propofol, the infusion rate will be adjusted according to the BIS values (30 <BIS <50). Patients will receive additional remifentanil by infusion at 0.02 mcg/kg/min per time if blood pressure and heart rate values exceed 20% pre-operative baseline values. Additional rocuronium 0.1 mg/kg based on clinical needs and TOF monitoring.
Analgesic starter bolus: 30 minutes before the end of the surgery, paracetamol 1 gr ev and ketorolac 30 mg ev.
Postoperative pain: paracetamol 1 gr ev every 8 hours for 36 hours; ketorolac 30 mg ev if NRS >4 / morphine 2 mg ev if NRS >4 30 min after ketorolac administration. In case of nausea and vomiting ondansetron 4 mg ev. Receives: Procedure: General anesthesia + ESP block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain control
Evaluate the difference between the two groups regarding post-operative pain using Numeric Rating Scale (NRS) 0= better outcome; 10=worse outcome Score will be measured on the numeric rating scale (NRS), an NRS ≤ 4 will be considered as effective antalgic coverage.
Measured: 12 hours
Secondary outcomes (6)
Intra operative use of opioids.
Mcg of Remifentanil consumed during surgery.
Measured: Surgery time.
Post operative use of non-steroidal anti-inflammatory drugs
Mg of ketorolac or any others anti-inflammatory drugs administered after surgery.
Measured: 2-6-12-24-36 postoperative hours
Post operative use of opioids
Mg of opioids administered after surgery.
Measured: 2-6-12-24-36 postoperative hours
Postoperative nausea and / or vomiting
Quantity of antiemetic drugs required to control nausea and vomiting episodes
Measured: 2-6-12-24-36 postoperative hours
Days of hospital stay
The number of days of hospitalization after surgery will be assessed
Measured: 3 days
Assessment of patient satisfaction with the anesthesiological technique
Patients is requested to fill out a pre-printed sheet on their judgment of the anesthesiological procedure, in which they can express a value from 0 to 5, where 0 indicates "entirely dissatisfied" and 5 indi- cates "very satisfied"expressed by the patient according to the following scale: satisfied, very satisfied, not at all satisfied
Measured: 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start22 Feb 2021
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- AUSL Romagna Rimini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chiara Rosato, MD, Principal investigator, AUSL Romagna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839445
- Sponsor's protocol ID
- 2909
- Acronym
- ARTEMIDE
- Status last verified
- Apr 2022
- First submitted
- 5 Apr 2021
- Last updated
- 24 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jones JH, Aldwinckle R. Interfascial Plane Blocks and Laparoscopic Abdominal Surgery: A Narrative Review. Local Reg Anesth. 2020 Oct 23;13:159-169. doi: 10.2147/LRA.S272694. eCollection 2020.
PubMed 33122942Bagaphou CT, Santonastaso DP, Rispoli M, Piraccini E, Fusco P, Gori F. Bilateral continuous erector spinae plane block: an alternative to epidural catheter for major open abdominal surgery. Minerva Anestesiol. 2020 Sep;86(9):993-994. doi: 10.23736/S0375-9393.20.14557-7. Epub 2020 Jun 2. No abstract available.
PubMed 32490608
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Ultrasound-guided Erector Spinae Place Block Versus Transversus Abdominis Plane Block for Intra and Postoperative Pain Control in Total Laparoscopic Hysterectomy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04839445
- Acronym / sponsor ID
- ARTEMIDE / 2909
- Conditions
- Anesthesia, Gynecologic Cancer
- Keywords
- Transversus Abdominal Plane Block, Erector Spinae Plane Block, General Anesthesia, Laparoscopic Hysterectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- AUSL Romagna RiminiUniversity, hospital or other
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 9 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The anesthetic techniques for videolaparoscopic surgery include general anesthesia, and locoregional anesthesia in association with general anesthesia in order to reduce or abolish post-operative pain with a simultaneous reduction in the use of opioids and days of hospital stay.
From the studies published so far on videolaparoscopic surgery in general, it is clear that the transversus abdominal plane (TAP) block could have a role in reducing the stretch wall pain secondary to pneumoperitoneum and incisional, although its role in this regard is not yet clear, nor significant statistically results have been produced. The use of erector spinae plane (ESP) block for the management of visceral pain is finding more and more space in the literature, with promising results.
For videolaparoscopic gynecological surgery, the techniques of locoregional anesthesia studied in association with general anesthesia, up to now, include wall blocks, TAP block and ESP block, while neuraxial anesthesia has no indications in this regard.
Although videolaparoscopic hysterectomy is considered less painful than the open-abdomen technique, it requires careful management of post-operative pain. The pain of this surgery is the result of the sum of incisional pain, at the insertion points of the laparoscopic trocars, pain due to pneumoperitoneum usually referred to the shoulder, and visceral pain purely dependent on surgical maneuvers. There is currently no strong evidence to support the use of locoregional anesthesia techniques in videolaparoscopic gynecological surgery. Few studies have been produced about this topic, and they are mostly case series or randomized controlled trials that take into consideration only one technique among those possible. To date, no study compares the various techniques to evaluate the possible superiority of one over the other.
In our hospital anesthesists carry out, in normal clinical practice, all the aforementioned local anesthesia techniques.
The purpose of our work is to evaluate, with a randomized non-sponsored study, the efficacy of the ESP block and the TAP block for intra and post-operative pain control in videolaparoscopic hysterectomy, and to compare the two techniques.
Based on the evidence available in the literature, the two techniques are already part of the current clinical practice of the Anesthesia Unit of our hospital and the choice of one technique over the other is based on anesthetist clinical evaluation to date. The anesthetists involved in the study are adequately trained on both anesthetic procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General anesthesia + TAP block | Active comparator | Procedure: General anesthesia + TAP blockInduction: remifentanil in total intravenous anesthesia (TIVA), Propofol 2 mg/kg/h and Rocuronium 0.6 mg/kg. Transversus abdominis plane (TAP) block: 20 minutes before surgery. Ropivacaine 0.37% 20ml + dexamethasone 2mg per side. Maintenance: TIVA with Propofol, the infusion rate will be adjusted according to the bispectral index system (BIS) values (30 <BIS <50). Patients will receive additional remifentanil by infusion at 0.02 mcg/kg/min per time if blood pressure and heart rate values exceed 20% pre-operative baseline values. Additional rocuronium 0.1 mg/kg based on clinical needs and train of four (TOF) monitoring. Analgesic starter bolus: 30 minutes before the end of the surgery, paracetamol 1 gr ev and ketorolac 30 mg ev. Postoperative pain: paracetamol 1 gr ev every 8 hours for 36 hours; ketorolac 30 mg ev if NRS >4 / morphine 2 mg ev if NRS >4 30 min after ketorolac administration. In case of nausea and vomiting ondansetron 4 mg ev. |
| General anesthesia + ESP block | Active comparator | Procedure: General anesthesia + ESP blockErector spinae plane (ESP) block: 20 minutes before surgery. T8 level bilaterally, ropivacaine 0.37% 20ml + dexamethasone 2mg per side. Induction: Remifentanil in TIVA, Propofol 2 mg/kg/h and Rocuronium 0.6 mg/kg. Maintenance: TIVA with Propofol, the infusion rate will be adjusted according to the BIS values (30 <BIS <50). Patients will receive additional remifentanil by infusion at 0.02 mcg/kg/min per time if blood pressure and heart rate values exceed 20% pre-operative baseline values. Additional rocuronium 0.1 mg/kg based on clinical needs and TOF monitoring. Analgesic starter bolus: 30 minutes before the end of the surgery, paracetamol 1 gr ev and ketorolac 30 mg ev. Postoperative pain: paracetamol 1 gr ev every 8 hours for 36 hours; ketorolac 30 mg ev if NRS >4 / morphine 2 mg ev if NRS >4 30 min after ketorolac administration. In case of nausea and vomiting ondansetron 4 mg ev. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American society of anesthesiologists (ASA) I-III risk
- no contraindication to the execution of the peripheral nerve block
- signature of the informed consent
- total videolaparoscopic surgery (no conversion to open-abdomen)
Key exclusion criteria (4 listed)
- allergies and / or contraindications to the administration of the drugs used in the study
- infections and injuries at the puncture site
- BMI ≥40
- history of opioid abuse or use of opioids in chronic therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| General anesthesia + TAP blockPost induction TAP block for intra and postoperative analgesia. | Procedure or surgery | General anesthesia + TAP block |
| General anesthesia + ESP blockPre induction ESP block for intra and postoperative analgesia. | Procedure or surgery | General anesthesia + ESP block |
Primary outcome
Postoperative pain control
Time frame: 12 hours
Evaluate the difference between the two groups regarding post-operative pain using Numeric Rating Scale (NRS) 0= better outcome; 10=worse outcome Score will be measured on the numeric rating scale (NRS), an NRS ≤ 4 will be considered as effective antalgic coverage.
6 secondary outcomes
Intra operative use of opioids.
Time frame: Surgery time.
Post operative use of non-steroidal anti-inflammatory drugs
Time frame: 2-6-12-24-36 postoperative hours
Post operative use of opioids
Time frame: 2-6-12-24-36 postoperative hours
Postoperative nausea and / or vomiting
Time frame: 2-6-12-24-36 postoperative hours
Days of hospital stay
Time frame: 3 days
Assessment of patient satisfaction with the anesthesiological technique
Time frame: 36 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
- Results publication: PubMed 33122942Jones JH, Aldwinckle R. Interfascial Plane Blocks and Laparoscopic Abdominal Surgery: A Narrative Review. Local Reg Anesth. 2020 Oct 23;13:159-169. doi: 10.2147/LRA.S272694. eCollection 2020.
- Results publication: PubMed 32490608Bagaphou CT, Santonastaso DP, Rispoli M, Piraccini E, Fusco P, Gori F. Bilateral continuous erector spinae plane block: an alternative to epidural catheter for major open abdominal surgery. Minerva Anestesiol. 2020 Sep;86(9):993-994. doi: 10.23736/S0375-9393.20.14557-7. Epub 2020 Jun 2. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Anesthesia
RecruitingPhase 4
Adding Dexmedetomidine or Clonidine to Spinal Anesthesia for Cesarean Delivery
Cesarean Delivery, Cesarean Delivery; Neuraxial Opioids
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
Recruiting
Hyperangulated vs. Macintosh Style Blades for Intubation in Obstetric Patients
Obstetric, Cesarean Birth
Recruiting
The Effects of Midazolam, Dexmedetomidine, and Esketamine on Bispectral Index and Raw Electroencephalogram in Patients Under Propofol-Remifentanil Baseline Anesthesia
Depth of Anesthesia Monitoring, BIS-EEG
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chiara Rosato, MD principal investigator
AUSL Romagna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General anesthesia + TAP block and General anesthesia + ESP block in people with Anesthesia and Gynecologic Cancer, run by AUSL Romagna Rimini at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain control (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04839445, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2022; AzTrials last refreshed its copy on 30 Oct 2026.